DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I and the species of Gln33STOP in the reply filed on 9/16/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-9 and 48-52 are pending. Claims 10-47 and 53-77 have been cancelled.
Claims 48-52 have been withdrawn as being drawn to a nonelected invention.
An action on the merits for Claims 1-9 is set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4-9 are indefinite over “when the subject is TREM2 reference” in claim 4 and 5. This phrase is unclear as it is not clear the metes and bounds of “TREM2 reference” as it is not clear how “TREM2 reference” correlates to the determining TREM2 variant.
Claims 4-9 are indefinite over the phrase “developing a more severe form of Alzheimer’s Disease” in claim 4. The term “a more severe form” in claim 4 is a relative term which renders the claim indefinite. The term “a more severe form” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular as there is no comparison it is unclear which forms of Alzheimer’s Disease would be considered “more severe”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schware et al. (WO2017/062672 April 13, 2017).
With regard to claim 1, Schware et al. teaches administering an TREM2 agonist to a subject with Alzheimer’s disease (para 14-16).
With regard to Claim 2, Schware et al. teaches that the subject can have a mutation that leads to loss of function (para 14).
With regard to claim 3, Schware et al. teaches a start loss variant (para 48)
With regard to claim 4-6, Schware et al. teaches administering an TREM2 agonist to a subject with Alzheimer’s disease (para 14-16). Schware et al. teaches determining that the subject has a TREM2 variant genotype (para 48). Schware et al. teaches to continue to administer treatment to patients with heterozygous variant of TREM2 with a TREM2 agonist (para 48, 413-415). It is noted that it is not clear the mete of TREM2 reference and as such it is interpreted as encompassing a variant of TREM2.
With regard to claims 7-9, Schware et al. teaches detection of Gln33STP which would be the nucleic acids that encompass 6:41161557G:A (para 48). As Schware et al. teaches the same variant the variant as encompassed by Schware et al. would encompassed the claimed cDNA structure.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682